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Vice-President Quality & Regulatory
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Medical Devices organization, based in Zürich Switzerland.
My client is a start-up company in the Medical Devices business. They are highly innovative and rapidly growing. They are expecting to have their first product in the market at the end of the year, and therefore they are looking for a seasoned QARA professional who is willing to lead the quality and regulatory affairs departments.
You will be leading the QA and RA departments (currently in total 4 people, but growing to 8-10 in the end of 2016) and help the company getting their product approved on the European market. Next to this, you will set up the traject for the introduction of the Class III device in the US market and thus work towards FDA approval. You will be part of an exciting and young environment in the area of Zurich. Your position will report directly to the CEO and the COO, and together with the CCO and CTO, you will be part of the executive board.
- Manage the introduction of a Class III Medical Device
- Lead ISO 13485 implementation
- Work towards FDA implementation
- Lead a team of 4, with growth to 8-10 in QA and RA
- Lead and hire external consultants
- Degree in Engineering or Life Sciences
- Very strong knowledge of ISO 13485, MDD 93/42/EEC and FDA 21 CFR part 820
- Demonstrate ability to build up teams in a fast changing environment
- Experience in the same kind of positions in other start-ups is a big plus
- Fluent English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.